- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06886035
Effectiveness of Curcuminoids in Controlling Postoperative Pain Following Total Laparoscopic Hysterectomy
Total hysterectomy is one of the most common surgical procedures in gynecology. Total laparoscopic hysterectomy (TLH) has several advantages over open surgery, such as better cosmetic outcomes, faster recovery, and an earlier return to normal activities and work, and has thus become the preferred approach Nonetheless, postoperative pain (PP) remains an issue of concern.
The reported incidence of PP after TLH ranges from 35 % to 63 %. The origin of PP after laparoscopy is multifactorial, arising from several perioperative factors, including pneumoperitoneum, stretching of the intraabdominal cavity, blood left in the abdomen, and dissection of the pelvic region. A prospective trial found more intense pain and greater analgesia requirement in the immediate postoperative period associated with laparoscopic surgery than with laparotomy. Methods to decrease the severity of PP are required before TLH can be confidently recommended.
Curcumin has several benefits, which are endorsed by the World Health Organization (WHO).
That is, it can be used to treat dyspepsia and peptic ulcer. Moreover, it has anti-inflammatory and analgesic properties. Most benefits are attributed to its anti-oxidant and anti-inflammatory effects. Curcuminoid is the active ingredient of turmeric. Curcuminoids are used in laparoscopic surgery because of their aforementioned benefits. Further, the use of traditional medicine, which is low-cost and effective in improving postoperative pain due to abdominal diştention, is assessed.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
-
Muğla, Turkey (Türkiye), 35460
- Muğla Sıtkı Koçman University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
-Laparoscopic total hysterectomy and salpingectomy, with the option of additional procedures such as oophorectomy, uterosacral ligament plications, trans obturator tape insertion, or sentinel lymphadenectomy candidates
- They should be able to understand and sign an informed consent
- They should be literate enough to understand the maintenance of a diary recording pain scores, QoL-15 scores, and any adverse event
Exclusion Criteria:
Patients with any peripheral or central neuropathic pain
- Patients used to taking over-the-counter painkiller pills
- Patients with a history of alcohol intake/drug dependence
- Patients with a history of psychosis
Patients with chronic inflammatory diseases who cannot be taken off nonsteroidal anti-inflammatory drugs (NSAIDs)/painkillers
• Patients on immunosuppressive/cytotoxic/steroid therapy.
- American Society of Anesthesiologists physical status classification of ≥ IV
- known hypersensitivity to curcumin; current opioid use for any indication;
- concurrent procedures for deep infiltrating endometriosis, sacrocolpopexy,
- concomitant intestinal surgery
- refusal to participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Study Group
Our clinical ERAS (Enhanced Recovery After Surgery) protocols were implemented to study patients.
The study group also began a regimen of 100 mg oral liposomal curcumin (administered as 50 mg twice daily) one day before the procedure.
Following surgery, oral liposomal curcumin (50 mg twice daily) was restarted 8 hours postoperatively and maintained for an additional two days.
|
The study group began a regimen of 100 mg oral liposomal curcumin (administered as 50 mg twice daily) one day prior to the procedure.
Following surgery, oral liposomal curcumin (50 mg twice daily) was restarted 8 hours postoperatively and maintained for an additional two days.
( A total dose 300 mg)
|
|
Placebo Comparator: Control Group
Our clinical ERAS (Enhanced Recovery After Surgery) protocols were implemented to control patients without any additional intervention (Placebo drug: Identical-appearing placebo capsules were administered at the same time points and dosing schedules.)
|
The study group began a regimen of 100 mg oral liposomal curcumin (administered as 50 mg twice daily) one day prior to the procedure.
Following surgery, oral liposomal curcumin (50 mg twice daily) was restarted 8 hours postoperatively and maintained for an additional two days.
( A total dose 300 mg)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the visual analogue scale (VAS)
Time Frame: 24 hours after surgery
|
The primary goal was to assess the variation in postoperative pain levels recorded on the VAS (scored from 0 to 10, where 0 represents no pain and 10 represents the worst pain imaginable) 24 hours after surgery
|
24 hours after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ariyasriwatana C, Phoolcharoen N, Oranratanaphan S, Worasethsin P. Efficacy of Curcuminoids in Managing Postoperative Pain after Total Laparoscopic Hysterectomy: A Randomized Controlled, Open-Label Trial. Complement Med Res. 2022;29(3):223-227. doi: 10.1159/000521669. Epub 2022 Jan 5.
- Nurullahoglu KE, Okudan N, Belviranli M, Oz M. The comparison of preemptive analgesic effects of curcumin and diclofenac. Bratisl Lek Listy. 2014;115(12):757-60. doi: 10.4149/bll_2014_146.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neurologic Manifestations
- Nervous System Diseases
- Neurobehavioral Manifestations
- Perceptual Disorders
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Agnosia
- Antineoplastic Agents
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Inflammatory Agents
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Antirheumatic Agents
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Anti-Inflammatory Agents, Non-Steroidal
- Curcumin
Other Study ID Numbers
- M07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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